228. 閉塞性細気管支炎
[臨床試験数:92,薬物数:125(DrugBank:34),標的遺伝子数:33,標的パスウェイ数:152

Searched query = "Bronchiolitis obliterans", "Obliterating bronchiolitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
28 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04655508
(ClinicalTrials.gov)
March 202110/11/2020Efficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 =10% From Pre TransplantationEfficacy of Fluticasone Propionate Associated With Salmeterol Using Inhalation Chamber Versus Placebo to Improve the Respiratory Function in Children Over Six Years of Age Who Underwent Allogeneic Hematopoietic Stem Cell Transplantation With a Decline of FEV1 =10% From Pre TransplantationStem Cell Transplant Complications;Respiratory Disease;Bronchiolitis ObliteransDrug: Seretide;Drug: PlaceboAssistance Publique - Hôpitaux de ParisGlaxoSmithKlineNot yet recruiting6 Years17 YearsAll243Phase 3France
2EUCTR2019-002987-29-AT
(EUCTR)
23/04/202021/01/2020Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
3NCT04039347
(ClinicalTrials.gov)
March 3, 202019/7/2019Open-Label, Extension Trial to Demonstrate the Effectiveness and Safety of L-CsA Plus Standard of Care in the Treatment of BOS in Patients Post Single or Double Lung TransplantA Phase III, Multicenter Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosprine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single or Double Lung TransplantationBronchiolitis Obliterans;Obliterative Bronchiolitis;Bronchiolitis Obliterans SyndromeDrug: Liposomal Cyclosporine A 5 mg;Drug: Liposomal Cyclosporine A 10 mgBreath Therapeutics Inc.NULLEnrolling by invitation18 YearsN/AAll220Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
4EUCTR2019-002987-29-ES
(EUCTR)
28/02/202020/12/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
5EUCTR2019-002987-29-DE
(EUCTR)
12/02/202026/11/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis Obliterans Syndrome after Single or Double Lung Transplantation.A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation Bronchiolitis Obliterans Syndrome in Patients post Single or post Double Lung Transplantation
MedDRA version: 20.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Germany;United Kingdom;France;United States;Belgium;Spain;Austria;Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-003204-39-GB
(EUCTR)
21/10/201914/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
7EUCTR2018-003205-25-GB
(EUCTR)
11/09/201914/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
8EUCTR2018-003205-25-AT
(EUCTR)
02/04/201904/12/2018Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
9NCT03656926
(ClinicalTrials.gov)
March 29, 201930/8/2018A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and RejectionDrug: Liposomal Cyclosporine ABreath Therapeutics Inc.NULLRecruiting18 YearsN/AAll110Phase 3United States;Austria;Belgium;France;Germany;Israel;Spain;United Kingdom
10NCT03657342
(ClinicalTrials.gov)
March 26, 201930/8/2018A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantA Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Single Lung TransplantationBronchiolitis Obliterans;Chronic Rejection of Lung Transplant;Lung Transplant Rejection;Lung Transplant; Complications;Lung Transplant Failure and RejectionDrug: Liposomal Cyclosporine ABreath Therapeutics Inc.NULLRecruiting18 YearsN/AAll110Phase 3United States;France;Germany;Israel;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-003205-25-DE
(EUCTR)
04/03/201915/11/2018Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United States;France;Spain;Belgium;Austria;Israel;Germany;United Kingdom
12EUCTR2018-003205-25-ES
(EUCTR)
01/03/201918/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after double lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2 Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
110 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;Spain;Austria;Israel;Germany;United Kingdom
13EUCTR2018-003204-39-DE
(EUCTR)
20/02/201915/11/2018Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Liposomal Cyclosporine A
Product Code: L-CsA
INN or Proposed INN: Ciclosporin (Ciclosporinium)
Other descriptive name: CICLOSPORIN A
BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;France;Spain;Israel;Germany;United Kingdom
14EUCTR2018-003204-39-ES
(EUCTR)
08/02/201918/01/2019Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Spain;Israel;Germany;United Kingdom
15EUCTR2018-003204-39-FR
(EUCTR)
09/01/201913/11/2018Clinical research study to investigate effectiveness and safety of Liposomal Cyclosporine A (L-CsA) in patients with Bronchiolitis obliterans syndrome after single lung transplantation.A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation - BOSTON-1 Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]BREATH Therapeutics Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Israel;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01469364
(ClinicalTrials.gov)
March 20138/11/2011Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung TransplantationComplication of Transplanted LungDrug: Aztreonam Lysine for Inhalation (AZLI);Procedure: Status Post Lung TransplantDuke UniversityGilead SciencesCompleted18 YearsN/AAll30Phase 4United States
17EUCTR2011-004304-38-ES
(EUCTR)
19/09/201222/06/2012An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
18EUCTR2011-004304-38-GB
(EUCTR)
14/06/201209/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
19EUCTR2011-004304-38-AT
(EUCTR)
13/03/201220/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 15.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
20NCT01273207
(ClinicalTrials.gov)
March 2, 20127/1/2011Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransExtension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis ObliteransBronchiolitis Obliterans;Constructive Bronchiolitis;Graft Versus Host Disease;Bronchiolitis, Exudative;Bronchiolitis, Proliferative;Graft-Versus-Host DiseaseDrug: Cyclosporine Inhalation Solution (CIS)National Heart, Lung, and Blood Institute (NHLBI)NULLCompleted10 Years80 YearsAll7Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-004304-38-BE
(EUCTR)
14/02/201215/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Spain;Belgium;Denmark;Austria;Germany;United Kingdom
22NCT01439958
(ClinicalTrials.gov)
February 201222/9/2011Long-term Safety Follow-up Study in the Prevention of Bronchiolitis Obliterans Syndrome (BOS)A Long-term Safety Follow-up Study of L-CsA Therapy for Patients Who Participated in Study 12011.201 and Volunteered to Continue or to Cross-over to L-CsA Inhalation TherapyBronchiolitis ObliteransDrug: InhalationPari Pharma GmbHNULLTerminated18 Years80 YearsBoth14Phase 3Germany
23EUCTR2011-004304-38-DK
(EUCTR)
20/01/201219/12/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy - Not applicable Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.1;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3France;Canada;Belgium;Spain;Austria;Denmark;Germany;United Kingdom
24EUCTR2011-004304-38-DE
(EUCTR)
06/01/201228/11/2011An open-label safety extension study for those patients who participated in protocol 10211.201 and wish to continue therapy with L-CsAA long-term safety follow-up study of L-CsA therapy for patients who participated in study 12011.201 and volunteered to continue or to cross-over to L-CsA inhalation therapy Prevention of Bronchiolitis Obliterans Syndrome in lung transplant
MedDRA version: 14.0;Level: LLT;Classification code 10049202;Term: Bronchiolitis obliterans;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Aerolised Liposomal Ciclosporin A 5mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
Product Name: Aerolised Liposomal Ciclosporin A 10mg
Product Code: L-CsA
INN or Proposed INN: Ciclosporin
Other descriptive name: Ciclosporine, Ciclosporina
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
40France;Canada;Belgium;Spain;Denmark;Austria;Germany;United Kingdom
25NCT01287078
(ClinicalTrials.gov)
January 29, 201129/1/2011Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans SyndromePhase II Trial of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for Treatment of Bronchiolitis Obliterans SyndromeConstrictive Bronchiolitis;Bronchiolitis Obliterans;Graft vs Host Disease;Bronchiolitis, Exudative;Bronchiolitis, ProliferativeDrug: Cyclosporine Inhalation SolutionNational Heart, Lung, and Blood Institute (NHLBI)NULLCompleted10 Years80 YearsAll25Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01334892
(ClinicalTrials.gov)
December 200911/4/2011L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) PatientsA Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled Clinical Trial to Investigate the Efficacy and Safety of Aerosolised Liposomal Ciclosporin A Versus Aerosolised Placebo in the Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant PatientsBronchiolitis ObliteransDrug: Cyclosporine Inhalation SolutionPari Pharma GmbHNULLTerminated18 YearsN/ABoth130Phase 2/Phase 3Germany
27NCT00755781
(ClinicalTrials.gov)
September 200817/9/2008Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung TransplantationA Multi-Center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung TransplantationLung TransplantDrug: Cyclosporine Inhalation Solution (CIS)APT Pharmaceuticals, Inc.NULLCompleted18 YearsN/ABoth284Phase 3United States;Canada
28NCT00378677
(ClinicalTrials.gov)
February 200720/9/2006Dry Powder Inhalation of Cyclosporine A in Lung Transplant Patients With Bronchiolitis Obliterans SyndromePilot Study of Cyclosporine A Dry Powder Inhalation in Lung Transplant Patients With Bronchiolitis Obliterans SyndromeLung Transplantation;Bronchiolitis ObliteransDrug: Cyclosporine A dry powder inhalation (Drug)University Medical Centre GroningenNULLRecruiting18 YearsN/ABoth7Phase 0Netherlands